MAUDE Adverse Event Report: EBI, LLC. SPINALPAK STIMULATOR, BIOMET; STIMULATOR, SPINAL PAK, NON-INVASIVE

Model Number	N/A
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint (b)(4).B3: date of event: the event occurred sometime in (b)(6) 2023.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported by the sales rep that the patient stated she was feeling pain when using stim.The sales rep directed patient to discontinue until further instruction from zimvie.Csr-- tanesha littlejohn call patient left message for patient to call back regarding pain.No product to return, no replacement product sent to the patient.Update 06/08: as per product surveillance specialist michael salvati, the patient was called regarding the pain.The patient stated that she feels a pain and a burning sensation below the skin.The patient described it as a "bone pain." the patient stated that the pain starts about 4-5 hours after starting treatment with the unit and she described the pain level as a nine out of ten.The patient stated that the pain lasts for 10-12 hours after she stops treatment.The patient spoke to the doctor and was told to continue treatment.Nothing was prescribed by the doctor.The patient stated that she has not been treating and will be seeing her doctor again in a few weeks.
Event or Problem Description
It was reported that the patient stated she was feeling pain when using stim.The sales representative directed patient to discontinue until further instruction from zimvie.No product to return, no replacement product sent to the patient.It was later reported that the patient was called regarding the pain.The patient stated that she feels a pain and a burning sensation below the skin.The patient described it as a "bone pain." the patient stated that the pain starts about 4-5 hours after starting treatment with the unit and she described the pain level as a nine out of ten.The patient stated that the pain lasts for 10-12 hours after she stops treatment.The patient spoke to the doctor and was told to continue treatment.Nothing was prescribed by the doctor.The patient stated that she has not been treating and will be seeing her doctor again in a few weeks.No additional information was received at this time.No further consequences have been reported.The spinal pak device was not returned for evaluation.
Additional Manufacturer Narrative
Corrections: b4 date of this report, b5 updated the product was not returned for evaluation, d3 manufacturer address and email address, d4 unique identifier (udi) number, g1 contact office, and manufacturer site, g6 type of report.Additional information: g3 date received by manufacturer, h4 device manufacture date, h6 component, investigation type, findings, and conclusions, h10 and h11.This follow-up report is being submitted to relay additional and corrected information.The device was not returned to highridge medical for evaluation.The reported event was unable to be confirmed due to limited information received from the customer.The device history record/certificate of conformance was reviewed, and no discrepancies related to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Highridge medical will continue to monitor for trends.

• Brand Name: SPINALPAK STIMULATOR, BIOMET
• Common Device Name: STIMULATOR, SPINAL PAK, NON-INVASIVE
• Manufacturer (Section D): EBI, LLC.; 1 gatehall dr; suite 303; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC; 1 gatehall dr; suite 303; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 17102135
• Report Number: 0002242816-2023-00072
• Device Sequence Number: 1907733
• Product Code: LOF
• UDI-Device Identifier: 00812301020225
• UDI-Public: 00812301020225
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P850022
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: N/A
• Device Catalogue Number: 1067717
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/10/2023
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic